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Trial of Switching Between Intravitreal Bevacizumab (Avastin®)& Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)

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ClinicalTrials.gov Identifier: NCT01787669
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : November 13, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of Sydney

Brief Summary:

The specific aim of the study is to test the following hypothesis:

That switching between treatments from bevacizumab to Ozurdex or vice versa in eyes with diabetic macular oedema with no or incomplete response from one therapy is beneficial.


Condition or disease Intervention/treatment Phase
Diabetes Diabetic Macular Oedema Diabetic Macular Edema Diabetic Retinopathy Drug: Avastin (Bevacizumab) Drug: Ozurdex (dexamethasone) Phase 2

Detailed Description:
A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Clinical Trial of Switching Between Intravitreal Bevacizumab (Avastin®) and Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema (SwitchDMO)
Study Start Date : June 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Avastin (bevacizumab)
Intravitreal Avastin loading doses followed by as prn for remainder of 6 months according to defined retreatment criteria
Drug: Avastin (Bevacizumab)
Avastin (Bevacizumab) administered intravitreally

Active Comparator: Ozurdex (dexamethasone)
single dose at baseline and repeat dose when required according to defined re-treatment criteria
Drug: Ozurdex (dexamethasone)
Ozurdex (dexamethasone) given intravitreally




Primary Outcome Measures :
  1. Proportion of eyes that have central macular thickness <300 microns 6 months after switching [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mean change in central macular thickness (CMT) as measured by OCT. [ Time Frame: 6 months ]
    Mean change in central macular thickness (CMT) as measured by OCT.


Other Outcome Measures:
  1. Mean change in BCVA (best corrected visual acuity) [ Time Frame: 6 months ]

    Proportion of eyes with a gain of 15 LogMAR letters or more

    • Proportion of eyes with a loss of less than 15 LogMAR letters
    • Proportion of eyes with gain of 5 LogMAR letters or more
    • Proportion of eyes with gain of 10 LogMAR letters or more



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eyes Previously Treated with bevacizumab:

  1. Diabetic macular oedema affecting the fovea that has persisted despite ongoing, monthly intravitreal injections of bevacizumab over at least 6 months, the last being 2 to 3 months prior to the screening visit.
  2. There must be an historical OCT available from 1-4 weeks after the last bevacizumab injection with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to bevacizumab.
  3. At screening, the bevacizumab treated eye must have DMO with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT

    Eyes Previously Treated with dexamethasone:

  4. Diabetic macular oedema affecting the fovea that has persisted despite two dexamethasone implants 5 or fewer months apart, the last being 5-8 months prior to the screening visit.
  5. There must be an historical OCT available from 8-14 weeks after the last dexamethasone implant with retinal thickness > 300 microns in the central 1mm subfield on Spectral domain OCT to show the lack of complete response to the dexamethasone implant.
  6. At screening, the dexamethasone treated eye must have DMO with retinal thickness > 300 microns in central 1mm subfield on Spectral domain OCT
  7. Age >= 18 years
  8. Diagnosis of diabetes mellitus
  9. Best corrected visual acuity of 20-78 letters (approx 6/120 -6/7.5)
  10. Previous macular laser treatment, or the investigator believes laser treatment is unlikely to be helpful
  11. Intraocular pressure <22mmHg
  12. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised
  13. Written informed consent has been obtained.

Exclusion Criteria:

  • Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar TA within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months.
  • Cataract surgery within the last 3 months
  • Retinal laser treatment within the last 3 months
  • For eyes to be switched to Dexamethasone: Patient considered, at the judgement of the investigator, to be at-risk for syphilis, tuberculosis or other potentially infective chorioretinopathies. Patients considered at-risk may be assessed at the investigators discretion to reasonably exclude these conditions. Should these conditions be excluded, the patient may be considered for enrolment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787669


Locations
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Australia, New South Wales
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2000
Australia, Victoria
Centre for Eye Research Australia (Royal Victorian Eye & Ear Hospital)
Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Lions Eye Institute
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
University of Sydney
Allergan
Investigators
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Principal Investigator: Samantha FRASER-BELL SAVE SIGHT INSTITUTE, UNIVERSITY OF SYDNEY, SYDNEY EYE HOSPITAL
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT01787669    
Other Study ID Numbers: SwitchDMO
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Keywords provided by University of Sydney:
diabetic macular oedema
diabetic macular edema
diabetic retinopathy
dexamethasone
Ozurdex
Avastin
bevacizumab
DME
DMO
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Edema
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Dexamethasone
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones